Segmented orthosis with a pulley mechanism for fitting adjustment

ABSTRACT

A segmented lumbosacral orthosis with two side members conjoined by a cord threaded through an array of seamless tubes that are independently mounted and swivel from an axis point proximal to the end points of each tube. Each tube array is housed in a mounting bracket made from a continuous piece of material folded over to form a gap in between two sides. Each mounting bracket is attached to a side member by sliding a pin along the folded edge of the bracket through knuckles (or loops) attached to the side member similar to a hinge. A removable posterior member is connected to each posterior end of the side members using an elastic material that expands and contracts in parity with the mechanical advantage closure system. The removable posterior panel is designed to hold a rigid or semi-rigid insert stored in three separate sections: one in a center compartment juxtaposed by one on each side that sway along a vertical axis.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of application Ser. No.13/775,190 which is a continuation application of application Ser. No.13/460,778 which claims benefit to provisional application 61/480,466,filed on Apr. 29, 2011, entitled “Segmented Orthosis with a Quasi-PulleyMechanism for Fitting Adjustment, all three of these applications areincorporated by reference herein in their entireties.

BACKGROUND OF THE INVENTION

The present invention relates to orthosis and, more particularly, to asegmented orthosis with a pulley mechanism for fitting adjustment.

Orthosis braces on the market include a variety of closure systems toconjoin and hold a support member(s) in a desired position once it iswrapped around a location on the body. This type of medical device canbe applied around the torso to support the low back, the leg to supporta knee, etc. Some of the existing closure systems found on orthosisbraces include: (1) belts and/or straps that are pulled and securedusing hook and loop fastening methods; (2) threading cord through aseries of eyelets; and (3) threading cord around a series of pulleys.The use of cord and pulleys is commonly known as a mechanical advantagesystem, which can also include substitutes for a pulley, such as a fixedposition vertical post or a layering of members to form a channel.

Patients with certain medical conditions may have limited grip strengthor range of motion, and therefore have difficulty achieving arecommended compression level when applying an orthosis brace. In thesecases, the lack of restrictive movement or bodily support impacts theclinical efficacy while wearing an orthosis. To assist patients withmeeting the physical requirements to properly tighten an orthosis brace,a closure system designed with mechanical advantage offers great easeand usability.

Orthosis braces that are currently available on the market with amechanical advantage closure system have the following deficiencies: (1)they can integrate an array of narrow eyelets that abruptly change acord's vector to an acute angle thus causing the cord to move unevenlywhen pulled; (2) they can wrap a cord around a fixed position, straight,vertical post or protrusion off a base, which allows a cord to shiftalong the length of the vertical axis when drawn; (3) they can have cordlengths that are not easily shortened by a patient to reduce the armextension distance required to achieve a tight form fit around thetreatment area; (4) they can be difficult to center against thetreatment area without stopping to shift the orthosis prior to reachingthe maximum applied forces; (5) they do not allow the closure system tobe easily separated from the connecting support members for routinecleaning, maintenance, repair, and/or replacement; (6) they can havefully exposed elements that protrude outward enough to unexpectedly getcaught on an object(s) thus creating a safety hazard; (7) they canintegrate a rigid support member with a pre-determined shape and/orcontour, which may not conform to every patient's anatomical shapeand/or size; (8) they do not include an anterior rigid or semi-rigidinsert that can be moved laterally left or right for horizontalrealignment; and (9) they can be expensive to produce due to the numberand complexity of custom shaped or molded components required for theclosure system.

Orthosis devices with strap or belt closure systems can be difficult totighten around the torso for patients inflicted with certain medicalcondition(s), such as arthritis, muscle weakness, limited range ofmotion, etc. As a result of wearing an orthosis with an inadequate orloose fit around a bodily location, the treatment outcome can be lesseffective for the patient. In addition, supportive rigid or semi-rigidinserts that are not correctly or consistently positioned against abodily location can have an adverse effect on the treatment outcome.

As can be seen, there is a need for an improved orthosis device that hasa mechanical advantage closure system.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exterior view of an orthosis device, according to anembodiment;

FIG. 2 is an interior view of the orthosis device of FIG. 1, accordingto an embodiment;

FIG. 3 is a front view of a side member insert that may optionally beused in the orthosis device of FIG. 1, according to an embodiment;

FIG. 4 is a front view of another embodiment of a side member insertthat may optionally be used in the orthosis of FIG. 1, according to anembodiment;

FIG. 5 is an exploded interior view of a removable posterior member usedin the orthosis device of FIG. 1, according to an embodiment;

FIG. 6 is an exterior view of the removable posterior member of FIG. 5with an elastic positioner positioned in a first position, according toan embodiment;

FIG. 7 is an exterior view of the removable posterior member of FIG. 5with the elastic positioner positioned in a second position, accordingto an embodiment;

FIG. 8 is exterior view of the orthosis device of FIG. 1 with theremovable posterior member of FIG. 5, according to an embodiment;

FIG. 9 is an interior view of the orthosis device of FIG. 1 with theremovable posterior member of FIG. 5, according to an embodiment;

FIG. 10 is a partially exploded view of a portion of the orthosis deviceof FIG. 8, according to an embodiment;

FIG. 11 is a perspective view of the orthosis device of FIG. 8,according to an embodiment;

FIG. 12 is a front view of a mechanical advantage closure system used inthe orthosis device of FIG. 1, according to an embodiment;

FIG. 13 is front view of a pulley mounting bracket used in themechanical advantage closure system of FIG. 12, according to anembodiment;

FIG. 14 is a front view of another pulley mounting bracket used in themechanical advantage closure system of FIG. 12, according to anembodiment;

FIG. 15 includes an exploded and a perspective view of a pulley assemblyused in the mechanical advantage closure system of FIG. 12, according toan embodiment;

FIG. 16 is a top view of the pulley system of FIG. 15, according to anembodiment;

FIG. 17 is a partially exploded, partially cut-away view of the pulleymounting bracket used in the mechanical advantage closure system of FIG.12, according to an embodiment;

FIG. 18 is a perspective view of an alternate embodiment of a pulleyassembly used in a mechanical advantage closure assembly for theorthosis device of FIG. 1, according to an embodiment;

FIG. 19 is a perspective view of another alternate embodiment of apulley assembly used in a mechanical advantage closure assembly for theorthosis device of FIG. 1, according to an embodiment;

FIG. 20 is a drawing of a pulley assembly used in the mechanicaladvantage closure system of FIG. 12 with an opening in the carrier,according to an embodiment;

FIG. 21 is a drawing of an inner alignment tool and outer alignmenttools used to assist insertion of a respective tube, according to anembodiment; and

FIG. 22 is a drawing of a pulley mounting bracket with a hole in eachend cap and a threaded pin, according to an embodiment.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description is of the best currently contemplatedmodes of carrying out exemplary embodiments of the invention. Thedescription is not to be taken in a limiting sense, but is made merelyfor the purpose of illustrating the general principles of the invention,since the scope of the invention is best defined by the appended claims.

Various inventive features are described below that can each be usedindependently of one another or in combination with other features.

An embodiment of the present invention provides a segmented lumbosacralorthosis with mechanical advantage that integrates two side membersconjoined by cord threaded through an array of seamless tubes that areindependently mounted and swivel from an axis point proximal to the endpoints of each tube. Each tube array is housed in a mounting bracketmade from a continuous piece of material folded over to form a gap inbetween two sides. Each mounting bracket is attached to a side member bysliding a pin along the folded edge of the bracket through knuckles (orloops) attached to the side member—similar to a hinge. A removableposterior member is connected to each posterior end of the side membersusing an elastic material that expands and contracts in parity with themechanical advantage closure system. The removable posterior panel isdesigned to hold a rigid or semi-rigid insert stored in three separatesections: one in a center compartment juxtaposed by one on each sidethat sway along a vertical axis. Each side member is capable of storinga removable rigid or semi-rigid insert that can be repositioned along ahorizontal axis to provide anterior support.

The pulley (or “quasi-pulley”) design is based on a seamless segment ofround tubing that is turned to an angle of approximately 180 degrees,and mounted to a rotating carrier. A tube's cross-sectional shape isgeometrically round or convex and conforms to the cross-sectional shapeof a preferred cord allowing it to slide smoothly and evenly in twodirections through a plurality of pulleys.

Referring to FIGS. 1 through 17, a lumbosacral orthosis 2 may integratea mechanical advantage closure system designed to pull together firstand second side members 4, 6. The side members 4, 6 may be wrappedaround the torso of a user for an anatomically contoured fit. The sidemembers 4, 6 may be made of a flexible base material, such as fabric,foam, or the like, which has an exposed pile on one or both sidesforming loops for compatibility with hook fasteners. Hook fasteners area connection mechanism that can be used to connect two surfacestogether, such as VELCRO (which uses a first surface comprising hooksand a second surface comprising loops which cooperate to sticktogether). The outer shape of the side members 4, 6 may be comprised ofboth rectilinear and curvilinear lines. The side members 4, 6 may becapable of storing a rigid or semi-rigid material as an anteriorsupport. The first side member 4 may connect to second side member 6through a posterior pulley system and an anterior fastener 32. Theanterior fastener 32 may be a hook fastener used to close the anteriorportion of the orthosis 2 by attaching the interior side of the firstside member 4 to the exterior side of the second side member 6. The hookfastener may be sewn into the first side member 4 and may attach to theloop pile of the second side member 6.

Binding 8 may be a fabric material sewn along exposed edges of the sidemembers 4, 6 to provide reinforcement and an aesthetically pleasingappearance. The binding 8 can be made of, for example, cotton,polyester, polyester-cotton blend, nylon, and the like.

Anterior support may be provided by rigid or semi-rigid inserts 34, 36that can be added or removed from compartments 24, 26 within theorthosis 2. The inserts 34, 36, once inserted into the compartment 24,26 of the side members 4, 6, may provide anterior support when thedevice is wrapped firmly against the torso. The anterior insert canslide along the length of the compartment's interior for optimalclinical efficacy. When the anterior inserts 34, 36 are within both sidemembers 4, 6 and the side members 4, 6 are overlapped, the rigidity andsupport may increase. Alternatively, a clinician can reduce the amountof anterior support by removing one or both rigid inserts 34, 36. Theinserts 34, 36 may be made from, for example, plastic, such aspolyethylene, polypropylene, or acrylonitrile-butadiene-styrene (ABS).The outer shape of the inserts 34, 36 may include both rectilinear andcurvilinear lines.

The compartments 24, 26 may optionally hold other items, such as a hotpack, a cold pack or the like. The item in the compartments 24, 26 maybe horizontally shifted left to right within the compartments 24, 26 toadjust the placement for optimal clinical efficacy. The compartments 24,26 may be made of, for example, a 3-D spacer mesh that is sewn to theside members 4, 6. A hook fastener 28 for the compartments 24, 26 may beattached to the inside of the compartments 24, 26 to seal and unseal anopen end of the compartments 24, 26. The hook fastener 28 can attach tothe loop pile side of the side members 4, 6. A ribbon 30 may be used foraesthetic purposes to cover the stitched edge that joins the 3-D spacermesh to the hook fastener 28 on the first side member 4. The ribbon 30can be made from, for example, polyester, nylon, or a combinationthereof.

A side member posterior insert 20 may provide posterior support when theorthosis 2 is wrapped firmly against the torso of a user. The insert 20may be made from plastic, such as polyethylene or polypropylene. Theouter shape of the insert 20 may include both rectilinear andcurvilinear lines. A cover 22 for the insert 20 may be overlaid on topof the insert 20 and permanently stitched to a side member 4, 6. Thecover 22 may be made from a flexible base material, such as fabric,foam, or the like, which has an exposed pile on one or both sides,forming loops for compatibility with hook fasteners. The outer shape ofthe cover 22 may include both rectilinear and curvilinear lines.

A posterior support member 38 may store a centralized rigid orsemi-rigid insert 48, along with two juxtaposed supports 44 that maysway to varying degrees, all of which rest against the lumbosacral areafor an anatomically contoured fit. The support member 38 may attach anddetach from interior ends of the side members 4, 6. A center compartment58 of the posterior support member 38 may be formed between an interiorpanel 40 and an exterior panel 42 of the support member 38. The panels40, 42 may each have loop properties on both sides thereof. A hookfastener 46 may be disposed near the opening of the center compartment58, between the panels 40, 42, to open and close the compartment 58. Thecentral compartment 58 may store accessories, such as a rigid orsemi-rigid insert 48, a hot pack, a cold pack or the like. The removableposterior panel 38 may be attached to the first and second side members4, 6 that attaches to hook fasteners 52 which are affixed to a segmentof elastic 50 that expands and contracts. First and second side members4,6 comprise loop fasteners or material with loop properties to attachto the hook fasteners 52. This method of fastening the removableposterior panel 38 may provide quick attachment to and detachment fromthe orthosis 2, and may allow the center point of the removableposterior panel 38 to be adjusted both horizontally and vertically.

Once inserted into the compartment 58 of the posterior member 38, theinsert 48 may provide posterior support against the lumbosacral areawhen the device is wrapped firmly against the torso. The insert 48 maybe made of, for example, flexible plastic, such as polyethylene orpolypropylene. Alternatively, the insert 48 may be made from a rigidmaterial plastic, such as acrylonitrile-butadiene-styrene (ABS). Theouter shape of the insert 48 may include both rectilinear andcurvilinear lines. In some embodiments, the insert 48 may be formed as aframe-shaped member, similar to the insert 48 of FIG. 5, except acentral section of material removed. This configuration may provide lesspressure on a user's spine, for example, while still providing lateralsupport. In other embodiments, the compartment may be formed as twocompartments formed on each side of the compartment 58. This may beaccomplished, for example, by sewing a seam on each side of thecompartment. In each of these compartments, an insert may be disposed.In this configuration, no part of the insert may cross over the user'sspine.

An elastic positioner 50 may be used to set the horizontal and verticalalignment of the posterior member 38 against the posterior sections ofthe side members 4, 6. The elastic property of the positioner 50 allowsit to expand and contract in parity with the interstitial space formedbetween the side members 4, 6 once it is attached to each respectiveend. Hook fasteners 52 may be used to attach both ends of the elasticpositioner 50 to the respective ends of each side member 4, 6. When thebrackets 60 a 60 b are pulled closer together (or farther apart) theelastic positioner 50 can adjust in size (by virtue of it being elastic)to cooperate with the change in distance between the brackets 60 a 60 bthus maintain the connection of the support member 38 to the sidemembers 4, 6. While one elastic positioner 50 is shown in the figures,any appropriate number of elastic positioners 50 could be used. Forexample, two or more elastic positioners 50 may be positioned at theposterior member 38.

A center attachment point 54 may include a stitch, or an alternativefastener method, adapted to secure the elastic positioner's midpointagainst the exterior panel 42 of the posterior member 38. In alternateembodiments, the elastic positioner 50 may be formed using two or morepieces, spaced apart from one another, with each piece secured againstthe exterior panel 42 of the posterior member 38. A sway line 56 may bea vertical stitch that helps encapsulate the lateral rigid or semi-rigidinserts 44 while, at the same time, forms the sides of the centercompartment 58. In addition, it allows the posterior panel to becomeconcave in shape and thus conform to the natural contour of a patient'slumbosacral area.

As the orthosis 2 is cinched around the torso, the first and second sidemembers 4, 6 may glide over the exterior side of the removable panel 38encapsulating lateral supports 44. The supports 44 may be placed betweenthe interior and exterior panels 40, 42 of the removable posteriormember 38. The supports 44 may be made from a flexible plastic, such aspolyethylene or polypropylene. The outer shape of the supports 44 mayinclude both rectilinear and curvilinear lines.

The mechanical advantage closure system may be operated by a pull member14 attached to a cord 18 that loops through a series of opposing pulleyassemblies 74 to expand or contract the interstitial space between thefirst and second side members 4, 6. The cord 18 may be made from abraided aramid fiber, such as KEVLAR. Alternatively, the cord 18 couldbe made from a braided carbon fiber. In other embodiments, the cord 18could be made from braided natural or synthetic fibers, such as nylon,polyester, or a combination thereof. The pulley assembly 74 may be basedon a seamless segment of round tubing 78 bent approximately 180 degreesfrom one end to the other. The tube's 78 lack of seams and convex shapeallow a cord 18 to slide evenly and with reduced friction. In addition,by placing the tube 78 in a carrier 76 that rotates, the pulley assembly74 can pivot left and right along a plane as the cord changes its path.

A sliding cord guide 16 may be designed to feed cord through open loopsat each end and limit the vertical movement of the cord once the deviceis secured around the torso. The sliding cord guide 16 may have a hookfastener on one side that may attach and detach to a point anywherealong the side member 4.

Since the mechanical system closure system is not permanently fastenedto the first or second side member 4, 6, it can be detached andre-attached for maintenance or repair purposes without rendering theentire orthosis 2 useless. For example, pulley mounting brackets 60 a,60 b may be removed by removing an end cap 88 and a pin 86 from thebrackets 60 a, 60 b. A pin round-over 62 may help hold the pin 86 inplace. The pin 86 may pass through at least one flexible knuckle 10 thatmay be attached to each side member 4, 6. The flexible knuckle 10 may bea flexible material, such as webbing, formed into an open loop at oneend, through which the pin 86 may pass through. A slot 12 may be formedin the side members 4, 6 for holding the ends of the brackets 60 a, 60b.

First and second pulley mounting brackets 60 a, 60 b may be made from acontinuous piece of material, such as metal or plastic, that is foldedover to form a gap between the newly formed top and bottom portions. Thebrackets 60 a, 60 b could have straight, beveled, and/or round corners.Each bracket may be used to mount pulley assemblies 74 using fasteners84. A fully assembled bracket, such as bracket 60 a, may be attached toa side member, such as side member 4. The brackets 60 a, 60 b could bemade from metal or plastic. Each bracket 60 a, 60 b may be made in anyappropriate length and may include any number of pulley assemblies 74.While FIG. 12, for example, shows 5 pulley assemblies 74 on one bracket60 a and 6 pulley assemblies 74 on bracket 60 b, any number of pulleyassemblies 74 may be used in each bracket 60 a, 60 b. Typically, onebracket may include one additional pulley assembly as compared to itscorresponding bracket. The size of each bracket 60 a, 60 b and thenumber of pulley assemblies 74 in each bracket may depend, for example,on the height and intended use of the orthosis.

First mounting bracket pulley fastener apertures 64 a, 64 b may bepre-punched or pre-drilled holes aligned in pairs that may be used toslide through a bushing 80 and round fastener 84 for the pulley assembly74. The bushing 80 and round fastener 84 could be made of, for example,metal, such as steel, bronze, and the like; or plastic, such as acetal,nylon, polypropylene, and the like. A mounting bracket pocket 66 may bea notch formed in the mounting bracket that receives the flexibleknuckle 10 affixed to a side member 4, 6—similar to a hinge. A cordtie-down aperture 68 may be a pre-punched or pre-drilled hole that maybe used to connect a cord end to a mounting bracket 60 a, 60 b. A cordeyelet aperture 70 may be a pre-punched or pre-drilled hole that allowsan eyelet to be passed through a mounting bracket to the top outersurface or plane. Second mounting bracket pulley fastener apertures 72a, 72 b may be pre-punched or pre-drilled holes aligned in pairs thatare used to slide through a bushing 80 and round fastener 84 for thepulley assembly 74. The bushing 80 and round fastener 84 could be madeof, for example, metal, such as steel, bronze, and the like; or plastic,such as acetal, nylon, polypropylene, and the like.

The pulley assembly 74 may be a seamless segment of round tubing 78shaped to an approximately 180 degree angle that may later be insertedinto a carrier 76 with two holes aligned to the open ends of the tube78. The tube's 78 geometric shape may limit the insertion depth throughthe carrier holes 76. A bushing 80 may be inserted into the tube carrier76 to hold the back end of the tube 78 in place thus limiting orpreventing forward or backward movement. The seamless tube carrier 76may be a continuous piece of material with a three dimensional shapethat includes two sets of holes: one is aligned for the two ends of theseamless tube 78; and another for the bushing 80. The carrier may servetwo main purposes: (A) to hold a seamless tube in place; and (B) toconnect the pulley assembly to a mounting bracket. The seamless tubecarrier 76 may have straight or round exterior corners and could be madefrom a metal, such as aluminum, steel, brass, and the like; or aplastic, such as nylon, ABS, and the like. When made from plastic, theinterior corners may include a fillet for structural reinforcement. Theouter shape could be rectilinear, curvilinear, or a combination thereof.The seamless tube 78 may be a segment of round tubing material made fromeither a metal, such as aluminum, steel, brass, or the like; or aplastic, such as nylon, ABS, or the like. The bushing 80 may be acylindrical material consisting of an open core that could be made fromeither a metal, such as aluminum, steel, brass, bronze, or the like; ora plastic, such as nylon, ABS, or the like. The bushing 80 may allow thetube carrier 76 to rotate left and right once attached to a mountingbracket 60 a, 60 b using a round fastener 84 with an outer diametersmaller than the inner diameter of the bushing 80.

A cord eyelet block 82 may be used to direct the cord as it is pulledacross a mounting bracket. Its design includes both exposed andunexposed portions. The exposed portions may be shaped as eyeletsprotruding upward through the mounting bracket, and a half roundprotruding outward from the side of the bracket to prevent the cord fromrubbing on a straight edge. The unexposed portion may rest inside thefirst mounting bracket aligned to apertures for receiving a roundfastener 84. The round fastener 84 may be used to attach the pulleyassembly 74 and cord eyelet block 82 to a mounting bracket. The fastener84 could be a metal semi-tubular rivet that passes through the aperturesin a mounting bracket, bushing, and tube carrier. Alternatively, thefastener 84 could be a two part interlocking male/female rivet designmade of either a metal or plastic.

The orthosis 2 of the present invention may include three main supportmembers, and a pulley system for mechanical advantage, which may work intandem with one another to form a lumbosacral orthosis. Two side supportmembers, which wrap around the left and right side of a torso, may beconjoined by a posterior pulley system affixed to the side members byremovable pins. A center posterior support member is affixed to each ofthe side members using hook fasteners, making its position adjustableand use optional. The first and second side support members andremovable posterior support member are made from non-elastic materialthat will restrict or limit its stretchability while being applied or inuse.

To provide the necessary bodily support and/or restrictive movement, theanterior rigid or semi-rigid inserts should be placed in the side membercompartments, and the posterior rigid or semi-rigid insert should beplaced in the center member compartment. In both cases, the compartmentscan be sealed by a hook fastener that affixes to the side membermaterial with loop properties.

The circumference of the orthosis is adjusted by a hook fastener andpulling a cord that loops through an array of pulleys, consisting ofseamless tubes mounted to a bracket attached to opposing ends of theside members. An initial fit is achieved by wrapping the orthosis aroundthe torso and affixing the two anterior ends of the side memberstogether. A more restrictive fit is achieved by the pulley system thatis designed to reduce the distance between the two posterior ends of theside members.

To use the orthosis 2, a gap may be set between the first and secondside members by releasing the cord tension through the pulleysystem—this gap may be reduced during a later step. The rigid orsemi-rigid inserts should be placed in the side member compartments andthe removable posterior compartment. Without these inserts, limitedsupport will be provided while wearing the orthosis. The compartments oneach side member are formed in part using a 3-D spacer mesh that mayprovide three key benefits: (1) air exchange or movement from onesurface to another; (2) visibility to see the position of an insert; and(3) a padding effect that enhances overall comfort. The side membercompartments may be designed to allow accessories, such as rigid orsemi-rigid inserts, to be moved horizontally left or right so they arealigned over the optimal anatomical location. Furthermore, the quantityor density of all removable inserts can be adjusted as needed by apractitioner.

The orthosis may be positioned around the torso of the user until theremovable posterior panel is centered to the lumbosacral area. The endof each side member may be pulled forward until it is tight against thebody, and then, may be connected together by affixing the hook fasteneron the first side member to the exterior side of the second side member.This initial closure method may be made possible by the hook fastenerbeing compatible with the second side member's loop property. A morerestrictive fit may still be necessary.

To make the final fitting adjustment, principles of physics have beenapplied to reduce the amount of force that is necessary to pull the sidemembers closer to one another using pulleys and cord. The invention hasreplaced a conventional grooved or convex pulley with a pulley comprisedof a seamless round tube, shaped like an arc with an approximately 180degree angle from open end to open end. The pulley may connect to acarrier designed to pivot from a point proximal to the cord.

While the seamless tube is one unique component to the pulley system,the method of connecting it to the apparatus may be equally important.The connection may be accomplished by inserting the open ends of theseamless tube into a carrier that may swivel around a pivot point. Sincethe seamless tube is arced to approximately 180 degrees, it may have alimited insertion distance into the carrier. Furthermore, the seamlesstube may be held in position by a bushing adjacent to the tube's backend—proximal to the open ends. The pulley assembly's structural designmay limit the tube's movement backwards or forwards thereby providingstability during use and operation. The bushing may have an outerdiameter slightly larger than the mounting bracket apertures to which itis aligned, an inner diameter slightly larger than an outer diameter ofthe round fastener, and it is slightly taller than the tube carrier.These properties of the bushing may result in two key benefits: (1) itlimits how much the top and bottom of the mounting bracket can be pulledtogether when a round fastener is attached; and (2) it allows the tubecarrier to swivel freely once a round fastener has been attached betweenthe top and bottom sides of a mounting bracket.

The seamless tubes can be made from metal, such as aluminum, brass, orsteel that has burrs removed and edges smoothed by sanding or filing.Alternatively, the seamless tube could also be made from plastic, suchas nylon, acrylonitrile-butadiene-styrene (ABS), or polypropylene. Inaddition, a seamless plastic tube could be reinforced by integratingother materials, such as fiberglass. Similarly, the tube carrier can bemade from metal, such as aluminum, brass, or steel that has burrsremoved and edges smoothed by sanding or filing. Alternatively, the tubecarrier could also be made from plastic, such as nylon,acrylonitrile-butadiene-styrene (ABS), or polypropylene. In addition, atube carrier could be reinforced by integrating other materials, such asfiberglass.

The advantages of using plastic to fabricate the pulley assembly wouldbe smooth and even cord movement, lightweight, and low production cost.Use of a particular metal(s) could be heavier and/or more durable thanplastic.

The cord itself may be made from an aramid fiber, commonly known asKEVLAR, which may be braided into a diameter smaller than the diameterof the seamless tubes. The cross sectional shape of the cord may beround, but it could also be braided to other geometrical shapes, such asa square. Alternatively, the braided aramid fiber could be used to makea monofilament with a diameter smaller than the diameter of the seamlesstubes. As described above, the cord may be made of any suitable cordmaterial, such as braided natural or synthetic fibers, such as nylon,polyester, a combination thereof, etc. The carriers 76 can be made ofany suitable material, such as any metal (e.g., aluminum, etc.) plastic,etc. The tubes can also be made of any suitable material, such asrubber, plastic, etc.

Friction can wear down the fibers in a cord thus resulting in itsfailure. To minimize cord friction and possible wearing, an insert maybe designed with a round edge protruding outward that is flush with theexposed edges of a mounting bracket and perpendicular to the cord.

Engaging the mechanical advantage system may be done by grabbing hold ofthe pull member and drawing the cord outward away from the body. As thecord is drawn, it may move through the pulleys, fastened to the sidemembers through mounting brackets, and reduce the interstitial spacebetween both side members. The mechanical advantage system may have anupper and lower set of pulleys that may be managed using a continuouspiece of cord threaded through two apertures to the underside of thefirst mounting bracket and knotted at each end. An eyelet block on thefirst mounting bracket, along with the repositionable cord guide, maylimit the possibility of the cord becoming tangled or twisted; andreduces wearing of the cord as it is drawn across the edge of the firstmounting bracket.

The output force created by drawing the cord through the pulleys mayoccur with even and smooth movement. To reduce drag, the pulleys mayswivel to change direction with the cord as it is pulled in a zigzagpattern. As the gap between both side members decreases a morerestrictive fit can be achieved. Once the side members have made contactwith each other the upper limit of applied input force has been reached.To maintain the current cord state, the pull member should be pulledacross the anterior portion of the orthosis and firmly engaged to a sidemember.

To remove the orthosis, the user may disengage the pull member from theside member and move it along with the cord away from the anteriorclosure section. Next, the user may disengage the hook fastener for theanterior closure of both side members and then fully remove the orthosisfrom the torso.

To make the invention work even better, the following elements could beadded: (1) both open ends of the seamless tube could be flared outwardto reduce or minimize cord friction as it moves in either direction. (2)Include two sets of protrusions on the underside of the first mountingbracket that are in close proximity to each cord tie-down aperture forthe purpose of winding or coiling unwanted cord length. Since aramidfibers can be very strong and difficult to cut, it would be helpful toprovide a simple method of shorting the cord length without requiringany tools. (3) Apertures could be added to the underside of the mountingbrackets, which would receive removable pins to enable and disable theswivel aspect of the pulley assemblies. This could be beneficial duringproduction of the invention because mounted pulleys would not move whilethreading the cord. (4) Include a method to place a marker that can beeasily repositioned to align with the anterior center point of apatient's waistline. This will assist a patient with centering theremovable posterior member, which is important for proper and consistentuse, as well as treatment outcome. The marker could be a continuous bandmade from a flexible material, such as webbing, that slides along thesecond side member and is held in position using a hook fastener on oneor both sides. Alternatively, the marker could be a segment thatattaches to either side of the second side member; or it could be a clipthe attaches to the edge(s) of the second side member. Color, labelswith text and/or graphics, or a combination thereof could be used toidentify the marker and its purpose.

Production could be Compartmentalized into the Following Procedures:

Fabricate Rigid or Semi-Rigid Inserts:

1. Die cut all removable and non-removable pieces of rigid or semi-rigidinserts.

Fabricate Pulley System:

1. Assemble a pull member by sewing a piece of flexible material arounda D-ring. Form a cord loop at the opposite end of the flexible materialand hold it together until permanently sewn with a reinforced stitch.Sew a piece of hook fastener to one side of the pull member that ispositioned between the D-ring and open loop.

2. Die cut or injection mold a set of mounting brackets complete withpre-punched or pre-drilled holes.

3. Place the cord aperture guide in the corresponding mounting bracketand push the eyelets up through the top side of the mounting bracket.

4. Fasten a rivet to secure the cord aperture guide to the mountingbracket.

5. Insert a segment of tubing arced to approximated 180 degree into thegap of a pulley carrier. Push the tube forward through the twocorresponding apertures in the pulley carrier until it does not move anyfurther.

6. Place a bushing through the apertures on the pulley carrier.

7. Insert the pulley assembly into the mounting bracket and align theapertures.

8. Install a round fastener (rivet) to the secure the pulley assembly tothe mounting bracket.

9. Repeat step 5-8 until all required pulley assemblies have beenattached to the mounting brackets.

10. Cut a segment of cord to required length.

11. Feed one end of the cord through the upper cord tie-down apertureand secure with a double knot on the underside of the mounting bracket.

12. Loop the unknotted cord end in a zigzag pattern by alternating itthrough the seamless tubes on the upper portion of the first and secondmounting brackets.

13. Feed the unknotted cord end through the upper cord eyelet on themounting bracket.

14. Feed the unknotted cord end through the upper loop on the slidingcord guide.

15. Feed the unknotted cord end through the cord loop on the pullmember.

16. Feed the unknotted cord end through the lower loop on the slidingcord guide.

17. Feed the unknotted cord end through the lower cord eyelet on themounting bracket.

18. Loop the unknotted cord end in a zigzag pattern by alternating itthrough the seamless tubes on the remaining lower portion of the firstand second mounting brackets.

19. Feed one end of the cord through the lower cord tie-down apertureand secure with a double knot on the underside of the mounting bracket.

Fabricate First and Second Side Members:

1. Cut the base material with loop properties on both sides to thedesired shapes and sizes.

2. Cut the 3-D spacer mesh to the desired shapes and sizes. Cut segmentsof hook fasteners and sew towards straight end of each piece of spacermesh. Sew binding material along straight edge of both pieces.

3. Cut hook fastener for attaching side members to the desired shape andsize. Align the straight edge of the hook fastener to the correspondingpiece of spacer mesh, and sew together with a stitch. Cover the seamwith a piece of ribbon cut to the desired length.

4. Cut the covers for the posterior supports to the desired shape andsize.

5. On the exterior side of the first side member, position and sew threesides of the cover material cut in step 4. Slide a rigid or semi-rigidinsert into the pocket through the remaining open end. Close the openend with a sewing stitch.

6. Form a flexible knuckle (or open loop at one end) using flexiblematerial and hold it together until permanently sewn onto the first sidemember with a reinforced stitch. Form a second flexible knuckle (or openloop at one end) using flexible material and hold it together untilpermanently sewn onto the first side member with a reinforced stitch.

7. Cut segments of flexible material to form slots used to tuck in theends of mounting bracket, and sew them to the first side member.

8. On the interior side of the first side member, position and sew theouter edges of the spacer mesh with the hook fastener to the basematerial.

9. Sew binding material around entire outer edge of first side member.

10. On the exterior side of the second side member, position and sewthree sides of the cover material cut in step 4. Slide a rigid orsemi-rigid insert into the pocket through the open end. Close the openend with a sewing stitch.

11. Form a flexible knuckle (or open loop at one end) using flexiblematerial and hold it together until permanently sewn onto the secondside member with a reinforced stitch. Form a second flexible knuckle (oropen loop at one end) using flexible material and hold it together untilpermanently sewn onto the second side member with a reinforced stitch.

12. Cut segments of flexible material to form slots used to tuck in theends of mounting bracket, and sew them to the first side member.

13. On the interior side of the second side member, position and sew theouter edges of the spacer mesh to the base material.

14. Sew binding material around entire outer edge of second side member.

Fabricate Removable Posterior Panel:

1. Cut the interior and exterior pieces using material with loopproperties on both sides to the desired shapes and sizes.

2. Cut segment of hook fastener and sew on upper end of interior piece.

3. Sew binding material along straight edge of interior piece that willform open end of compartment.

4. Cut a segment of elastic.

5. Cut two segments of hook fastener and permanently sew them to eachend of the elastic segment.

6. Position the segment of elastic to the horizontal and vertical centerpoint of the exterior piece, facing outward, and permanently affix itwith a reinforced sewing stitch.

7. Overlay both the interior and exterior pieces and sew verticalstitches to form sway line for lateral supports.

8. Slide a lateral rigid or semi-rigid insert between each open end ofthe interior and exterior pieces.

9. Sew binding material around entire outer edge of both the interiorand exterior pieces.

10. Slide rigid or semi-rigid insert into the center compartment. Sealthe open end with the hook fastener.

Final Assembly:

1. Align and place the two flexible knuckles on the first side memberwithin the pockets on the first mounting bracket. Slide a pin throughthe back side of the mounting bracket.

2. Bend each pin round-over to keep the pin snug against the back end ofthe mounting bracket.

3. Insert end caps into the first mounting bracket.

4. Tuck each end of the first mounting bracket into the correspondingslot on first side member.

5. Align and place the two flexible knuckles on the second side memberwithin the pockets on the second mounting bracket. Slide a pin throughthe back side of the first mounting bracket.

6. Bend each pin round-over to keep the pin snug against the back end ofthe second mounting bracket.

7. Insert end caps into the second mounting bracket.

8. Tuck each end of the second mounting bracket into the correspondingslot on second side member.

9. Affix pull member to the exterior side of first side member.

10. Slide rigid or semi-rigid insert into the interior compartment onfirst side member. Seal the open end with the hook fastener.

11. Slide rigid or semi-rigid insert into the interior compartment onsecond side member. Seal the open end with the hook fastener.

12. Place the first and second side members on a flat surface with theinterior side facing up. Affix removable posterior member to the firstand second side members using the hook fasteners on the elasticpositioner.

FIG. 20 is a drawing of a pulley assembly used in the mechanicaladvantage closure system of FIG. 12 with an opening in the carrier,according to an embodiment. FIG. 21 is a drawing of an inner alignmenttool and outer alignment tools used to assist insertion of a respectivetube, according to an embodiment.

To assist with the process of assembling the quasi-pulleys 74 a newcutout or opening 110 can be formed on the top side of a carrier 76 toreceive a custom fabricated inner alignment tool 112. The opening 110does not pass completely through a bottom of the carrier so that thetool 112 can fit securely inside the carrier 76. The inner alignmenttool 112 is used to help adjust the angle of a tube segment to achieveproper alignment. The opening 110 would span the distance between theinterior edges of the small holes, or beyond those two initial referencepoints. Alternatively, a single opening 110 could be replaced with twoor more smaller openings that equally allow a plurality of customtooling to be inserted for hole/channel alignment purposes. In additionto the inner alignment tool 112, outer alignment tools 114 could betemporarily inserted through the already open sides of a carrier 76 toform a set of restraints around each small hole. Both the inneralignment tool 112 and outer alignment tool 114 can have concave notches116, 117 and/or other semi-circle attributes that are designed togradually move the open ends of a tube towards the center point of eachrespective hole as it is being inserted. Once the tube is properlyinserted and the proper adjustments made, the custom alignment tools112, 114 would then be removed and the opening 110 would serve no otherpurpose. The custom alignment tools 112, 114 could be oriented in andout of position via a hand held operation; integrating them into amechanized machine; or a combination thereof. The custom alignment tools112, 114 are optional and embodiments can be made with only the inneralignment tool 112, only the outer alignment tool 114 or both.

An alternative (or an addition) to utilizing an inner alignment tool 112could include a floating block 118 that is placed between the inneredges of a tube 78 and the interior of a carrier 76. A floating block118 could have a dimensional height that is not greater than theinterior height of a carrier 76. The shape of a floating block 118 couldbe comprised of straight lines; curved lines; or a combination thereofas illustrated in FIG. 20. In addition, a floating block 118 could havesurfaces that are flat as illustrated in FIG. 20; surfaces that areconcave; or a combination thereof. The floating block 118 can be made ofany suitable material, such as any metal (e.g., aluminum, etc.),plastic, etc. and rests inside the inner edges of the tube 78 so thatwhen the tube 78 is in place inside the carrier 76 the floating block118 secures the tube 78 in place (see floating block 118 in FIG. 22).The floating block is optional.

FIG. 22 is a drawing of a pulley mounting bracket with a hole in eachend cap and a threaded pin, according to an embodiment. The cut-away(missing) portion of FIG. 22 is identical (i.e. symmetrical) to theportion shown.

To secure a pin 86 between two end caps 88 each end of the pin 88 can beinserted into a hole 124 built into each end cap 88. The end caps 88 (afirst end cap on one side and a second end cap on the other side) couldbe designed with a through hole 124 that spans the entire depth; or acounter-sunk hole 124 that spans only a fraction of the entire depth; orno hole as illustrated in FIG. 17; or a combination thereof.Additionally, the end of the pin 86 may be smooth or threaded 120 forthe purpose of creating a more secure fit with the end cap 88. An endcap 88 that receives a pin 86 with a smooth end will have a smoothcylindrical hole 124. An end cap 88 that receives a pin 86 with athreaded end 120 will have a tapped (threaded) hole 124 with compatiblethreads. To turn a threaded end 120 either clockwise or counterclockwisea driver head of any varying shape or size can be inserted into thecorresponding recessed shape located on the drive surface 122. Tofurther minimize movement, an end cap 88 with one or more protrusions(not illustrated) can snap, lock, or key into a mounting bracket 60 a,60 b with mating slots or cutouts.

It is noted that all parts, sections, surfaces, etc., that are to beremovably connected (attachable/detachable) can be done so usingfasteners such as VELCRO (which uses two cooperating materials, one oneach surface to be connected). “Hook fastener” and “loop fastener” asused herein refers to a fastener such as VELCRO (with cooperatingmaterial on each surface to be connected), e.g., if “loop” or “hook”fastener is used then the cooperating material is used on the othersurface, and “hooks” or “loops” as used herein can be substituted withthe other (with the cooperating material on the other surface to beconnected).

While the above describes an orthosis device for back support, variousfeatures described herewithin may be used for other types of orthosis.For example, the mechanical advantage closure system described above maybe useful for tightening other orthosis, such as knee, leg, arm, wrist,and other orthosis devices.

It should be understood, of course, that the foregoing relates toexemplary embodiments of the invention and that modifications may bemade without departing from the spirit and scope of the invention as setforth in the following claims.

What is claimed is:
 1. An orthotic device, comprising: a first sidemember comprising a plurality of first carriers; a second side membercomprising comprising a plurality of second carriers; each of theplurality of first carriers and the plurality of second carrierscomprises a top and a bottom and a front face and a hollow tube with twoopenings on the front face of the carrier; and a cord connecting thefirst side member and the second side member, the cord threaded throughthe plurality of first carriers and the plurality of second carriersthrough the respective hollow tubes; wherein at least one of theplurality of first carriers and at least one of the plurality of secondcarriers comprises a respective at least one opening.
 2. The device asrecited in claim 1, wherein the at least one opening is located at a topof the carrier.
 3. The device as recited in claim 1, wherein the atleast one opening is located on a side of the carrier.
 4. The device asrecited in claim 1, wherein the at least one opening is located on bothsides of the carrier.
 5. The device as recited in claim 2, wherein theat least one opening also comprises an opening located on a side of thecarrier.
 6. The device as recited in claim 2, wherein the at least oneopening also comprises an opening on each side of the carrier.
 7. Thedevice as recited in claim 2, further comprising an inner alignment toolshaped to fit through the opening at the top of the carrier.
 8. Thedevice as recited in claim 3, further comprising an outer alignment toolshaped to fit through the opening on the side of the carrier.
 9. Anorthotic device, comprising: a first side member comprising a pluralityof first carriers; a second side member comprising a plurality of secondcarriers; each of the plurality of first carriers and the plurality ofsecond carriers comprises a top and a bottom and a front face and ahollow channel with two openings on the front face of the carrier; acord connecting the first side member and the second side member, thecord threaded through the plurality of first carriers and the pluralityof second carriers through respective channels; and an inner alignmenttool shaped to fit through the opening at the top of the carrier,wherein at least one of the plurality of first carriers and at least oneof the plurality of second carriers comprises a respective at least oneopening located at a top of the carrier, wherein the inner alignmenttool comprises at least one concave notch.
 10. An orthotic device,comprising: a first side member comprising a plurality of firstcarriers; a second side member comprising a plurality of secondcarriers; each of the plurality of first carriers and the plurality ofsecond carriers comprises a top and a bottom and a front face and ahollow channel with two openings on the front face of the carrier; acord connecting the first side member and the second side member, thecord threaded through the plurality of first carriers and the pluralityof second carriers through respective channels; and an outer alignmenttool shaped to fit through the opening on the side of the carrier,wherein at least one of the plurality of first carriers and at least oneof the plurality of second carriers comprises a respective at least oneopening located on a side of the carrier, wherein the outer alignmenttool comprises a concave notch.
 11. An orthotic device, comprising: afirst side member comprising a plurality of first carriers; a secondside member comprising a plurality of second carriers; each of theplurality of first carriers and the plurality of second carrierscomprises a top and a bottom and a front face and a hollow channel withtwo openings on the front face of the carrier; a cord connecting thefirst side member and the second side member, the cord threaded throughthe plurality of first carriers and the plurality of second carriersthrough respective channels; and a tube positioned inside each channelin each of the plurality of first carriers and second carriers, whereinat least one of the plurality of first carriers and at least one of theplurality of second carriers comprises a respective at least oneopening.
 12. The device as recited in claim 1, wherein a second end ofthe first side member is configured to attach to a second end of thesecond side member.
 13. The device as recited in claim 1, wherein eachof the plurality of first carriers and the plurality of second carriersis configured to independently swivel.
 14. An orthotic device,comprising: a first side member comprising a plurality of firstcarriers; a second side member comprising a plurality of secondcarriers; each of the plurality of first carriers and the plurality ofsecond carriers comprises a top and a bottom and a front face and ahollow channel with two openings on the front face of the carrier; acord connecting the first side member and the second side member, thecord threaded through the plurality of first carriers and the pluralityof second carriers through respective channels; and a tube positionedinside each channel in at least one of the first carriers; and afloating block positioned between the tube.
 15. An orthotic device,comprising: a first side member comprising a plurality of firstcarriers; a second side member comprising a plurality of secondcarriers; each of the plurality of first carriers and the plurality ofsecond carriers comprises a top and a bottom and a front face and ahollow channel with two openings on the front face of the carrier; and acord connecting the first side member and the second side member, thecord threaded through the plurality of first carriers and the pluralityof second carriers through respective channels, wherein the first sidemember comprises an end cap that fits over a first side of the firstside member and an end cap that fits over a second side of the firstside member, the first side opposite the second side on the first sidemember.
 16. The device as recited in claim 15, wherein the end cap onthe first side of the first side member comprises a hole.
 17. The deviceas recited in claim 16, wherein the end cap on the second side of thefirst side member comprises a hole.
 18. An orthotic device, comprising:a first side member comprising a plurality of first carriers; a secondside member comprising a plurality of second carriers; each of theplurality of first carriers and the plurality of second carrierscomprises a top and a bottom and a front face and a hollow channel withtwo openings on the front face of the carrier; a cord connecting thefirst side member and the second side member, the cord threaded throughthe plurality of first carriers and the plurality of second carriersthrough respective channels; an end cap on a first side of the firstside member and an end cap on a second side of the first side member,wherein the end cap on the first side of the first side member comprisesa hole, wherein the end ca on the second side of the first side membercomprises a hole; and a pin between the hole on the first side of thefirst side member and the hole on the second side of the first sidemember.
 19. The device as recited in claim 18, wherein a first end ofthe pin is threaded and the hole on the first side of the first sidemember is threaded to receive the first end of the pin.
 20. The deviceas recited in claim 19, wherein a second end of the pin is threaded andthe hole on the second side of the first side member is threaded toreceive the second end of the pin.
 21. An orthotic device, comprising: afirst side member comprising a plurality of first carriers; a secondside member comprising a plurality of second carriers; each of theplurality of first carriers and the plurality of second carrierscomprises a top and a bottom and a front face and a hollow channel withtwo openings on the front face of the carrier; a cord connecting thefirst side member and the second side member, the cord threaded throughthe plurality of first carriers and the plurality of second carriersthrough respective channels; an end cap on a first side of the firstside member and an end cap on a second side of the first side member;and a pin which is shorter in length than a distance between the end capon the first side of the first side member and the end cap on the secondside of the first side member.
 22. An orthotic device, comprising: afirst side member comprising a first end and a second end, the firstside member comprising a plurality of first carriers; a second sidemember comprising a first end and a second end, the second side membercomprising a plurality of second carriers; each of the plurality offirst carriers and the plurality of second carriers comprises a top anda bottom and a front face and a hollow channel with two openings on thefront face of the carrier; a cord connecting the first side member andthe second side member, the cord threaded through the plurality of firstcarriers and the plurality of second carriers through respectivechannels; and a pin which is longer in length than a distance betweenthe end cap on the first end of the first side member and the end cap onthe second end of the first side member, wherein the first side membercomprises an end cap on a first end of the first side member and an endcap on a second end of the first side member.